Nitroglycerin for Migraine
Trial Summary
What is the purpose of this trial?
Migraine is the most common headache disorder, prevalent in 18% of females and 6% of males. Emergency room visits, physician consults, hospitalizations, medications, and indirect costs such as lost work days and decreased productivity place the global economic burden of migraines at over 20 billion dollars. It is prevalent in 28 million people in the US alone. Symptoms include unilateral, throbbing, debilitating headache pain accompanied by nausea, vomiting, photophobia, and phonophobia. Upwards of 75% of migraine patients have reduced functionability, have lost time at work, and 1/3 of patients require bed rest to manage the symptoms. The health-related impact on quality of life was comparable with that experienced by patients with congestive heart failure, hypertension, or diabetes. While the burden of migraines on our society is clear, the pathophysiology of migraines remains largely unknown. The trigeminovascular system, including the external and internal carotid arteries and their associated sensory fibers which subserve the head have long been implicated in the pain and cutaneous allodynia experienced by migraine patients. Wolff in 1953, was the first to posit that migraine headache pain is the caused by dilation or circumferential expansion of the extracranial carotid artery. He demonstrated that migraineurs had twice the pulse amplitude in their external carotid arteries compared to control subjects and these changes were directly correlated to migraine symptoms. In a 2008 study, randomized migraineurs received nitroglycerin via peripheral IV or placebo for 20 minutes prior to obtaining magnetic resonance angiography (MRA). Nitroglycerin, a potent dilator of blood vessels, reliably induced migraine-like pain in up to 80% of patients, and transient dilation of vessels of up to nearly 40%, mostly in the extracranial vessels. Sumatriptan's efficacy in migraine relief provides further evidence for this theory, as it is a selective extracranial vessel constrictor which does not cross the blood brain barrier. The goal of this current work is to utilize the direct, real-time angiography, which provides a high resolution map of vasculature, and demonstrate changes in vessel flow in patients who have migraine headache attacks. This information may guide therapeutic interventions in the future in order to better treat these migraine patients.
Do I need to stop my current medications for the trial?
You may need to stop taking certain medications, especially if they are vasoactive drugs or similar to nitroglycerin. The trial excludes participants taking these types of medications.
Is nitroglycerin generally safe for humans?
How does the drug nitroglycerin differ from other migraine treatments?
Nitroglycerin, also known as glyceryl trinitrate, is unique because it is typically used to provoke migraines in research settings rather than treat them. It works by releasing nitric oxide, which can cause headaches and mimic migraine symptoms, making it different from standard migraine treatments that aim to relieve or prevent symptoms.12346
Research Team
David J Altschul, MD
Principal Investigator
Montefiore Medical Center
Eligibility Criteria
This trial is for adults with a neurologist-confirmed diagnosis of migraine, experiencing migraines at least twice a month and not responding to standard treatments. Participants must have had stable neurological exams in the past 6 months and be willing to undergo angiography. Pregnant women, children, those with severe pulmonary or cardiac conditions, recent caffeine or alcohol intake, or on certain medications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-Angiography Evaluation
Participants undergo a clinic visit for history and physical evaluation, and complete a migraine questionnaire and headache log
Angiography and Immediate Post-Procedure Monitoring
Participants undergo angiography with nitroglycerin administration and vessel occlusion testing, followed by a 5-hour monitoring period
Follow-up
Participants complete a headache log and are monitored for migraine frequency and therapies utilized for 2 weeks post-angiogram
Treatment Details
Interventions
- Nitroglycerin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montefiore Medical Center
Lead Sponsor